MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE EXT SET W/MICROCLAVE®, MICROCLAVE® T-CONNECTOR, CLAMP, ROTATING LUE; STOPCOCK, I.V. SET

Model Number	Z1120
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device, a probable cause is unable to be determined.
Event or Problem Description
The event occurred on an unspecified saturday evening and involved a 7" smallbore ext set w/microclave®, microclave® t-connector, clamp, rotating luer.The customer reported that the intravenous (iv) tubing was leaking which resulted in blood loss on a neonate in icn 08.It was stated that the nurse went to give medications at 8 pm and saw that a small amount of total parental nutrition (tpn) and blood mixture had collected in the small tray in the patient's bed.Upon further investigation of the tubing and connections, the connections were found to be tight, but the fluids and blood were leaking at the hub.The device was then switched out and the neonatal nurse practitioner (nnp) was notified.About an hour later, the patient's blood pressure dropped and the nnp was notified again.A bolus of medication was then administered.The staff took the giraffe apart down to the area near the fan and they found a decent amount of blood and tpn that had accumulated there.All of the leakage was not initially visible because the connection was towards the bottom of the mattress and some leakage was later found in between parts of the patient¿s bed.The patient required a blood transfusion.The physician arrived to check on the baby and upon further investigation at that time, it was confirmed again that the connector was leaking.There was patient involvement and no harm.

• Brand Name: 7" SMALLBORE EXT SET W/MICROCLAVE®, MICROCLAVE® T-CONNECTOR, CLAMP, ROTATING LUE
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 12819243
• Report Number: 9617594-2021-00297
• Device Sequence Number: 11958876
• Product Code: FMG
• UDI-Device Identifier: 00887709022409
• UDI-Public: (01)00887709022409(17)260501(10)5353139
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: Z1120
• Device Catalogue Number: Z1120
• Device Lot Number: 5353139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GIRAFFE INCUBATOR, MFR UNK; UNSPECIFIED TPN, MFR UNK
• Patient Sex: Unknown